Director

9+ years

Not Disclosed

Bangalore

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Director, RA CMC Biologics & Rare Diseases
Location: Bangalore, India
Job Category: Regulatory Affairs & Safety Pharmacovigilance

Apply Now

About the Department:

The RA CMC organization at Novo Nordisk is expanding, and we are seeking a Director to join the RA CMC Biologics & Rare Diseases team. This newly established area is responsible for regulatory activities within Novo Nordisk’s biologics and rare diseases pipeline, as well as early life cycle management (LCM) of marketed products. You will lead a diverse team and collaborate closely with internal and external stakeholders, ensuring effective operations and business partnering to bring innovative and safe products to market.

The Position:

As the Director of RA CMC Biologics & Rare Diseases, you will:

Lead and develop a team of more than 30 colleagues with varying expertise, ensuring optimal employee development, planning, and resource utilization.
Drive team performance in alignment with the Novo Nordisk Way, focusing on skills development for current and future projects.
Ensure effective quality, compliance, and environmental management within the department.
Act as the key communication link within your team and with external stakeholders, including health authorities, agencies, vendors, and consultants.
Oversee the regulatory CMC activities for biologics and rare diseases products across their lifecycle.

Qualifications:

Education: Master’s degree or equivalent.
Experience: At least 8 years of relevant experience, including 5 years of leadership experience in regulatory affairs and/or CMC.
Proven leadership track record in aligning teams with strategic goals, while making tough decisions for the betterment of the organization.
Strong understanding of the Novo Nordisk value chain and ability to pursue goals even in the face of challenges.

Working at Novo Nordisk:

Novo Nordisk is a global leader in healthcare, with a 100-year legacy of advancing treatments for chronic diseases. With a focus on diabetes, obesity, and other serious conditions, we reach millions of patients worldwide. As one of the top 20 most valuable companies in the world, our success is driven by over 63,000 employees who work collaboratively toward transforming healthcare. Join us and help us make a meaningful difference in patients’ lives.

Application Deadline: Apply before 10th January 2025
To apply, please upload your CV through the online application portal.

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Director

Job Description

Apply Now

About the Department:

The Position:

Qualifications:

Working at Novo Nordisk:

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